A pragmatic, mixed-method trial is to show the ability of OtoSight to change management of the pediatric patient presenting with ear pain in a way that improves patient outcomes and reduces costs.
Mixed method, multi-center, pragmatic, cluster-randomized effectiveness-implementation investigation focused on pediatric subjects presenting with ear complaints at the office setting. For the prospective randomized component, eligible clinicians at a given site will be randomized to one of two groups: the OtoSight intervention group or the usual care control group. There will be three (3) periods of post-intervention assessment: 10 days (optional), 6 months, and 12 months. Eligible subjects will be automatically enrolled (or invited to enroll) in the clinical trial and will receive information. Because this is a non-interference design, frontline care clinicians randomized to either arm will be asked to: (1) assess the presence or absence of fluid in the middle ear; (2) record a diagnosis; and (3) treat the patient as they would according to the information available to them. A separate retrospective historical matched control arm will also be conducted to analyze potential Hawthorne effect at a subset of collaborating practices or healthcare systems. Randomization of clinicians (and not children) will decrease contamination in the usual practice group (i.e., so clinicians are not asked to flip between intervention and usual care practices).
Study Type
OBSERVATIONAL
Enrollment
700
Subjects will be evaluated with the OtoSight Middle Ear Scope
Children's National Hospital
Washington D.C., District of Columbia, United States
Abba Medical Group LLC
Miami, Florida, United States
AdventHealth Children's Research
Orlando, Florida, United States
Trillim Health
Rochester, New York, United States
Change the clinician rate of antibiotic prescriptions
Antibiotic stewardship
Time frame: Baseline to 12 month Follow Up
Change the number of antibiotic rounds per patient
Antibiotic stewardship
Time frame: Baseline to 12 month Follow Up
Change costs associated with management of pediatric patients presenting with ear-related pain
Change in overall costs
Time frame: Baseline to 21 month Follow Up
Change in unnecessary antibiotic prescriptions
Change in unnecessary antibiotic prescriptions based on reported diagnosis and treatment recommendations of providers
Time frame: Baseline to 12 month Follow Up
Change in prescription adherence
Change in prescription adherence
Time frame: Baseline to 12 month Follow Up
Change in antibiotic prescription rate when fluid not present
Change in antibiotic prescriptions rate when fluid is not present based on reported treatment recommendations of providers
Time frame: Baseline to 12 month Follow Up
Improve patient outcomes
Change in progression to recurrent AOM (rAOM) based on tracking provider diagnoses
Time frame: Baseline to 12 month Follow Up
Change medical resource utilization
Change in follow-up visit frequency, ENT (Ear, Nose, and Throat) referral frequency
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Cyn3rgy Research
Gresham, Oregon, United States
Carolina ENT
Orangeburg, South Carolina, United States
HealthStar Physicians
Morristown, Tennessee, United States
Time frame: Baseline to 30 days Follow Up
Change unnecessary medical intervention
Change in amount of unnecessary medical intervention (e.g., tympanostomy tube surgeries) based on tracking provider treatment recommendations and diagnoses
Time frame: Baseline to 12 month Follow Up
Impact clinician confidence
Change in clinician confidence scores reported on Provider CRF
Time frame: Baseline to 12 month Follow Up
Impact caregiver satisfaction
Change in clinician satisfaction scores reported on Provider CRF
Time frame: Baseline to 12 month Follow Up
Change in Health-related Quality of Life (HQoL)
Change in HQoL scores reported on the OMO-22 and OM-6
Time frame: Baseline to 12 month Follow Up